Submission Details
| 510(k) Number | K040635 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 2004 |
| Decision Date | March 30, 2004 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
CARRARA INTERACTION CERAMIC SYSTEM
Mar 2004
Decision
20d
Days
Class 2
Risk
About This 510(k) Submission
K040635 is an FDA 510(k) clearance for the CARRARA INTERACTION CERAMIC SYSTEM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 30, 2004, 20 days after receiving the submission on March 10, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.
Device Classification
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.6660 |
Manufacturer
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